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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121722052
Device Problem Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 08/14/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the cup (p/n: 121722052) and the impactor (manufactured by fuji flex, p/n: apjp0740) were not able to separate when the surgeon inserted the cup during the tha surgery of the patient¿s left hip joint on (b)(6) 2019.(the cup and the impactor had been remaining in inseparable after all) the surgery was completed by using another same size multi-hole type cup and a standard cup impactor.There was within a 30 minutes surgical delay and there was no adverse consequence to the patient.No further information is available.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : the device was reviewed by the manufacturer and root cause was concluded as undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The device was reviewed by the manufacturer cork, and a report was received stating; the failure mode was determined to be ¿unable to separate impactor tool from cup.¿ due to no similar failures found in the dhr (device history record) review, inability to confirm root cause due to damage of the thread during forced separation of the part from the impactor tool, and no similar complaints within an 18-month period, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.There is no patient risk as the affected part was not implanted.Product review: this would suggest that either the threaded apex hole on pinnacle cup from (b)(4) or the thread on the impactor tool would not meet specification.The complaint stated that the part (pinnacle cup) and the impactor tool were inseparable.On receipt of the returned part on site in depuy synthes, cork, just the part was received i.E.The impactor tool had been separated and removed prior to arriving at the manufacturing site.A visual inspection of the part was conducted and damage to the thread was observed.This damage was most probably caused due to the forceful separation of the part and the impactor tool.Due to the damage and contamination on the thread a dimensional inspection could not be completed on the part, therefore the thread could not be verified as to whether it was conforming to the required specification.Conclusion: the failure mode was determined to be ¿unable to separate impactor tool from cup.¿ due to no similar failures found in the dhr (device history record) review, inability to confirm root cause due to damage of the thread during forced separation of the part from the impactor tool, and no similar complaints within an 18-month period, the root cause of the complaint cannot be determined.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
 
Manufacturer Narrative
Product complaint # (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: corrected: device evaluated by mfr.Product complaint #(b)(4).Investigation summary: the device was reviewed by the manufacturer and root cause was concluded as undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
PINNACLE SECTOR II CUP 52MM
Type of Device
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8960506
MDR Text Key156450188
Report Number1818910-2019-103057
Device Sequence Number1
Product Code LPH
UDI-Device Identifier10603295009825
UDI-Public10603295009825
Combination Product (y/n)N
PMA/PMN Number
K000306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number121722052
Device Lot Number9159608
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Initial Date Manufacturer Received 08/14/2019
Initial Date FDA Received09/04/2019
Supplement Dates Manufacturer Received08/14/2019
11/05/2019
11/05/2019
12/18/2019
Supplement Dates FDA Received09/12/2019
11/05/2019
11/06/2019
12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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